Quality Engineer

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• Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities.
  
• Drive and implement plant wide quality system improvements.
  
• Drive and implement both the 9001 and 13485 standards.
  
• Ensure Regulatory compliance in area of responsibility to GMP's of all medical device regulatory agencies (e.g. NSAI, FDA and TUV)
  
• Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
  
• Customer complaints: Approval of analysis reports and analysis of complaint trend
  
• Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  
• Carry out document control as required.
  
• Support and drive the implementation of a new Quality software system (QPulse)
  
• Drive the Corrective Action module in Q Pulse.
  
• Perform internal quality audits.
  

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• 5 years’ experience in a manufacturing/med tech environment.
  
• Level 7/8 in an Engineering or Quality Discipline.
  
• Must understand Quality Engineering tools and methodologies.
  
• Hands-on experience with Lean Manufacturing techniques strongly desired. xcfaprz
  
• Must be familiar with ISO 9001 and ISO 13485 Standards.
  

Please call Michael O’Connor today for further information on or email